Vice President, Chemical Manufacturing and Control (VP-CMC)
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Job Location:
Waltham, MA - USA
Monthly Salary:
Not Disclosed
Posted on:
02-11-2025
Vacancies:
1 Vacancy
Job Summary
Vice President Chemical Manufacturing and Control (VP-CMC)
Skyhawk Therapeutics a clinical-stage biotechnology company is seeking a Vice President of Chemical Manufacturing and Control (CMC) to execute our rapidly expanding development pipeline of small molecule therapeutics. This role will be based at our Waltham MA site in the Boston metro area with flexible on-site work arrangements. The role will report directly to the EVP of Chemistry with responsibility to the C- Level leadership.
Responsibilities (including but not limited to):
- Accountable for executing the stage-appropriate supply of drug substance and drug product for the advancement of Skyhawks small molecule therapeutics from preclinical safety studies through clinical supply and commercial launch.
- Work with the Senior Leadership team to craft the nimble and efficient drug supply strategy from clinical through commercial.
- Select coordinate and execute with both consultants and Contract Research / Contract Development and Manufacturing Organizations (CRO / CDMO) to supply drug substance and drug product for Skyhawk programs.
- Supervise or collaborate with the Skyhawk team and subject matter expert consultants in CMC analytical chemistry quality assurance and regulatory affairs to ensure seamless and timely document preparation for stage-gate advancement.
Education/Skills/Experience:
Required
- PhD in synthetic organic chemistry with 10 years of relevant postgraduate industry experience
- An established track-record with prior small molecule CMC leadership position in minimally two of four listed organization types (Commercial-stage pharma pre-commercial biotech CRO CDMO)
- Demonstrated experience coordinating and authoring the drug substance and drug product sections of regulatory documents (for example IND NDA)
- Leadership skills consistent with a VP-level professional. These skills include active listening clarity in written and verbal expression and a flexible and enabling response to changes and challenges.
- An unwavering commitment to patients
Preferred but not required
- Prior CMC leadership in post-registration supply of a commercial product
- Bilingual fluency in English and Mandarin
About Skyhawk
Skyhawk is committed to discovering developing and commercializing small molecule therapeutics that modify RNA expression. We use our novel SkySTAR platform (Skyhawk Small molecule Therapeutics for Alternative splicing of RNA) to develop drug candidates directed toward targets for some of the worlds most intractable diseases including neurological conditions cancer and traditionally undruggable targets.
Required Experience:
Exec
Key Skills
- Change Management
- Financial Services
- Growing Experience
- Managed Care
- Management Experience
- Analysis Skills
- Senior Leadership
- Performance Management
- Process Management
- Leadership Experience
- negotiation
- Analytics
About Company
Skyhawk Therapeutics is a clinical-stage biotechnology company focused on the discovery and development of novel small molecule therapies designed to modulate critical RNA targets and revolutionize patient treatment for some of the world's most intractable diseases.
